EMEA-001613-PIP01-14-M04

Key facts

Active substance	tezepelumab
Therapeutic area	Pneumology-allergology
Decision number	P/0012/2020
PIP number	EMEA-001613-PIP01-14-M04
Pharmaceutical form(s)	Solution for injection
Condition(s) / indication(s)	Treatment of asthma
Route(s) of administration	Subcutaneous use
Contact for public enquiries	AstraZeneca AB (Sweden) Tel. +46 855326000 E-mail: paediatrics@astrazeneca.com
Decision type	PM: decision on the application for modification of an agreed PIP

Decision

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P/0012/2020: EMA decision of 6 January 2020 on the acceptance of a modification of an agreed paediatric investigation plan for tezepelumab (EMEA-001613-PIP01-14-M04) (PDF/250.25 KB) (new)

Adopted

First published: 12/06/2020
EMA/672331/2019

Related information

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Public summary of the evaluation of a proposed paediatric investigation plan: Human immunoglobulin G2Lambda monoclonal antibody directed against thymic stromal lymphopoietin (MEDI9929) for the treatment of asthma (PDF/88.57 KB)

First published: 17/02/2015
Last updated: 17/02/2015
EMA/66137/2015

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